[Federal Register Volume 60, Number 235 (Thursday, December 7, 1995)]
[Notices]
[Pages 62887-62891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29770]



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DEPARTMENT OF JUSTICE
[Docket No. 93-39]


William F. Skinner, M.D., Continuation of Registration

    On April 5, 1993, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to William F. Skinner, M.D., (Respondent) of Santa 
Monica, California, notifying him of an opportunity to show cause as to 
why DEA should not revoke his DEA Certificate of Registration, 
AS7287534, under 21 U.S.C. 824(a)(4), and deny any pending applications 
under 823(f), as being inconsistent with the public interest. 
Specifically, the Order to Show Cause alleged that:
    (1) During the period April 1987 through November 1988, the 
Respondent prescribed, administered, and dispensed excessive amounts of 
controlled substances to a single patient, including Demerol, Dilaudid, 
Xanax, Ativan, Percodan, Tylenol with Codeine, Valium, Percocet, 
Methadone, and Doriden, without a legitimate medical purpose and while 
not acting in the usual course of professional practice; and
    (2) During the same time period, the Respondent prescribed narcotic 
drugs to the same narcotic dependent patient for the purpose of 
maintenance treatment, and engaged in detoxification treatment of the 
patient without holding a separate DEA registration to conduct a 
narcotic treatment program.
    On April 27, 1993, the Respondent, through counsel, filed a timely 
request for a hearing. On February 23, 1994, the case was consolidated 
for hearing with Michael S. Gottlieb, M.D., Docket No. 93-53, and 
Michael J. Roth, M.D., Docket No. 94-10. Following prehearing 
procedures, a hearing was held in Los Angeles, California, on March 29-
30 and May 10-12, 1994, before Administrative Law Judge Paul A. Tenney. 
At the hearing, both parties called witnesses to testify and introduced 
documentary evidence, and after the hearing, counsel for both sides 
submitted proposed findings of fact, conclusions of law and argument. 
On October 17, 1994, Judge Tenney issued his Findings of Fact, 
Conclusions of Law, and Recommended Ruling, finding that Respondent's 
registration was not inconsistent with the public interest, and 
recommending that no action be taken against Respondent, Dr. Skinner. 
On November 8, 1994, the Government filed exceptions to Judge Tenney's 
opinion, and on December 7, 1994, the Respondent filed his response to 
the Government's exceptions. On December 12, 1994, Judge Tenney 
transmitted the record of these proceedings to the Deputy 
Administrator.
    The Deputy Administrator has considered the filings of the parties 
and the record in its entirety, and pursuant to 21 C.F.R. 1316.67, 
hereby issues his final order based upon findings of fact and 
conclusions of law as hereinafter set forth. The Deputy Administrator 
adopts, in full, the opinion and recommended ruling of Judge Tenney, 
and his adoption is in no manner diminished by any recitation of facts, 
issues and conclusions herein, or of any failure to mention a matter of 
fact or law.
    The Deputy Administrator finds that the Respondent is licensed to 
practice as a physician in the State of California, and that he had 
served as the medical director of the St. John's Hospital Chemical 
Dependency Center from 1981 

[[Page 62888]]
to 1990. He is registered with the DEA as a practitioner authorized to 
handle controlled substances in Schedule II through V.
    The DEA's allegations concern the Respondent's treatment of one 
patient, ``Patient A'', from March 1986 through October 1988. During 
this time period, Patient A had a number of significant physical 
conditions which caused pain, including pressure on the nerves from 
cervical degenerative joint disease; degenerative osteoarthritis of the 
lumbar vertebrae above a previous area where fusion surgery had been 
performed; spinal stenosis which occurs when the spinal canal narrows, 
at times putting pressure on a nerve with pain and muscle spasms; 
severe temporal mandibular joint degenerative disease; compression 
fracture of the patient's spine at L-1 and L-2; and trochanteric 
bursitis of the hip. Also during this time period, Patient A had a 
series of accidents which caused her acute pain: An automobile accident 
in which she was a passenger, resulting in a whiplash injury to her 
neck; an accident resulting in a knee injury; a fall down a spiral 
staircase, resulting in back strain; and a fall on a marble floor, 
resulting in a compression fracture of her spine. The record contains 
no evidence that drug intoxication caused any of these accidents.
    During the time period of March 1986 through October 1988, the 
Government contended that the Respondent prescribed controlled 
substances to Patient A for other than a legitimate medical purpose and 
not in the usual course of his professional practice. Beginning March 
20, 1986, the Respondent prescribed Demerol to Patient A. Demerol is a 
brand name for a medication containing meperidine hydrochloride, a 
Schedule II controlled substance. During the remainder of 1986, the 
Respondent prescribed Demerol and Percodan or Percocet, and 
occasionally he prescribed other Schedule II substances, such as 
Dilaudid, Doriden, and Tuinal. For example, from May 13 through 
December 26, 1986, the Respondent prescribed 1,604 tablets of Percodan 
or Percocet, and from March 20 through December 26, 1986, he prescribed 
approximately 30,000 milligrams of Demerol. This prescription practice 
continued into 1987 and 1988. However, also as a part of his 
prescription pattern, the Respondent tapered the amount of narcotics 
prescribed after the incidents of acute pain following the injuries 
suffered as a result of the various accidents. Dr. Smith, Dr. Ling, and 
Dr. Margoles testified that such tapering was within the usual course 
of professional practice.
    Also throughout this time period, the Respondent used various non-
narcotic methods of treating Patient A's pain. Specifically, he ordered 
bed rest, traction, hot packs, ultrasound, steroids, biofeedback, 
massage, electrocane, a cervical collar, facet blocks, physical 
therapy, acupuncture, and non-narcotic drugs. The Respondent also 
referred Patient A to numerous specialists, including Dr. Dodge, a 
neurosurgeon, Dr. Horacek, an orthopedic surgeon, and Dr. Woods, a 
neurologist.
    However, Dr. Skinner was the primary treating physician for Patient 
A, and his treatment records were included in the record of this case. 
The medical records recounted the Respondent's observations, 
examination results, and the prescriptions issued as a result of his 
house calls to Patient A. Further, the medical records also contain 
hospital test results, hospital admission, treatment and discharge 
records, and consultation reports. For example, the medical records 
show that Patient A was hospitalized during this time period. On July 
26, 1988, following a CAT scan, Dr. Joyce issued a report, writing that 
Patient A had a mild compression fracture at L1, mild stenosis at L2-3, 
moderate stenosis at L3-4, and a post-posterior bony fusion from L4 to 
the sacrum. Patient A was discharged on August 18, 1988. Again on 
September 29, 1988, Patient A was admitted to the hospital by Dr. 
Skinner, and she was discharged on October 4, 1988, with a diagnosis of 
a compression fracture, osteoporosis, and congenital scoliosis. On 
October 17, 1988, Patient A was again admitted with a complaint of 
severe left leg pain, and on October 23, 1988, she was discharged with 
the diagnosis of acute back pain secondary compression fracture of L1, 
acute lumbosacral spinal sprain and strain secondary to severe 
osteoarthritis at L2-3 with neuroforaminal narrowing, sciatica 
(resolved) and osteoporosis with high risk of possible spontaneous hip 
fracture.
    Further, as Judge Tenney noted, ``[t]here is a `debate' or 
difference of opinion between those [physicians who] specialized in 
addiction medicine and those in pain management regarding the use of 
narcotics for the treatment of severe pain.'' He also noted that Dr. 
Smith and Dr. Ling, the Government expert witnesses, were primarily 
experts in addiction medicine, and Dr. Margoles and Dr. Brechner, the 
Respondent's expert witnesses, were primarily experts in pain 
management. Dr. Smith and Dr. Margoles agreed that there exists a 
difference of opinion within the medical community as to the 
appropriate level of prescribing of controlled substances for the 
treatment of chronic pain patients. Also significant is the fact that 
the opinions of Dr. Brechner, Dr. Dodge, Dr. Horacek, and Dr. Woods 
were supported by either their personal examination, treatment, or 
both, of Patient A during the relevant time period, whereas the 
opinions of Dr. Smith and Dr. Ling were based upon their review of 
Patient A's treatment records and prescription documentation.
    Initially, the Government presented evidence from expert witnesses 
who had concluded that Patient A was addicted to controlled substances, 
and that the Respondent had prescribed medications to Patient A to 
maintain her addiction. On March 3, 1990, Dr. Smith wrote in a report 
for the District Attorney: ``[the] spectrum of medications [prescribed 
to Patient A] was not justified by the medical pathology and, in fact, 
the medications caused the patient far more harm than benefit. The 
dosage of medication was clearly excessive and the duration over the 
several month period as outlined in the medical records was both 
excessive and not justified by the medical pathology.'' He concluded 
that ``[a]s a result of this analysis it is my opinion then, that Dr. 
Skinner and his colleagues were not prescribing a narcotic medication 
primarily for the management of pain but, in fact, were maintaining her 
addiction.'' During the hearing before Judge Tenney, Dr. Smith, after 
reviewing the quantities of controlled substances prescribed on 
selected dates, testified that those quantities were excessive in light 
of the standard therapeutic dosage. He then restated the conclusion he 
had reached in his 1990 letter to the District Attorney.
    Based upon his review of Patient A's treatment record and relevant 
pharmacy records, Dr. Ling, a medical expert in the areas of neurology, 
psychiatry, addiction, and pain medicine, opined that the Respondent's 
prescribing practices did not meet the standard of care of the average 
practitioner with experience in the field of chemical dependency. He 
also testified that, in 1988, the standard of care was not to prescribe 
a large amount of narcotics, for such practice could result in the 
patient's developing a tolerance to controlled substances. He 
testified: ``You'd be treating the tolerance. You'd be treating 
addiction, you're no longer treating the [diagnosed medical 
condition].''
    Both Dr. Smith and Dr. Ling concluded that Patient A was an addict 
who was opiate dependent and 

[[Page 62889]]
benzodiazipine dependent. However, Dr. Ling also testified that he 
believed a drug dependent patient was entitled to treatment for pain, 
that Patient A was in pain, and that the Respondent was treating her in 
good faith.
    The Respondent presented evidence from consulting physicians who 
had concluded that Patient A was not an addict, but that she was 
dependent upon controlled substances for treatment of her chronic and 
sometimes acute pain. Specifically, Dr. Margoles, a medical expert in 
pain management, testified, after having reviewed Patient A's medical 
history and having interviewed her twice, that throughout the years 
1986 to 1988, Patient A had experienced intractable pain as a result of 
numerous medical problems and degenerative changes. He concluded that 
Patient A was a chronic pain patient, as opposed to an opioid abuser, 
and that she sought and was given medications to control her pain, not 
for euphoria. He found that, although Patient A had received an 
increase in amounts of opioids prescribed for her use, such an increase 
had resulted from the severity of her pain, not from addiction. He 
testified: ``It was obvious that the medication was being used to keep 
her going in her professional career.'' He also summarized the 
distinction between the use of pain medication to enable a patient with 
pain to function, and the use of narcotics to simply maintain an 
addict, as follows: ``the chronic pain patient * * * [is] goal 
oriented, they're working, they're functioning. They've got something 
in mind, they've got a goal. They're working, they've got a job. 
Narcotic maintenance is usually, as far as I'm concerned, * * * just 
keeping a person * * * from going through withdrawal symptoms.'' Also, 
he noted that there was no evidence in Patient A's records of abstinent 
syndrome, clinical or laboratory evidence of toxicity, nor evidence 
that she had sought drugs in order to obtain euphoria. Dr. Margoles 
testified that the lack of toxicity evidence meant that the ``patient 
obviously tolerated the medication that she had, that was used in her 
case, and evidently benefitted her [,] and [that] she had no toxic side 
effects * * * no slurred speech, inability to have cognitive speech, 
straight speaking.''
    Finally, Dr. Margoles noted that in the 1980's, guidelines were 
established in prescribing controlled substances for chronic 
conditions. These guidelines were indorsed by various medical and legal 
groups, to include the California Board of Medical Quality Assurance 
and the California Bureau of Narcotic Enforcement. Dr. Margoles 
testified that the Respondent's prescribing to Patient A met these 
standards.
    The Respondent also presented an affidavit from Dr. Dodge, a 
consulting neurosurgeon involved with the treatment of Patient A from 
1986 through 1988, who wrote:

    In my opinion, although the amounts of drugs were large compared 
to the average patient, they were necessary in order to treat the 
patient's pain. Although the patient clearly had a drug dependence 
problem, I do not believe the pain was controllable by other means 
besides narcotics. The amounts of narcotics tended to increase at 
the time of the acute events * * *. Dr. Skinner and the other 
physicians responsible for her care always attempted to minimize the 
amounts of drugs that she took and sought to detoxify her from those 
drugs when the acute phase of pain and muscle spasm from the 
injuries passed.
    In my opinion, Dr. Skinner and the other physicians responsible 
for her care did not violate the standard of practice in prescribing 
narcotic analgesics to this patient.

    Further, is an affidavit, Dr. Woods, a neurologist who treated 
Patient A from January 1987 to January 1988, made similar observations 
as Dr. Dodge, and concluded: ``In my opinion, Dr. Skinner and the other 
physicians responsible for her care did not violate the standard of 
practice in prescribing narcotic analgesics to this patient, in that 
the drugs were prescribed to control the patient's pain not to maintain 
her addiction.''
    As to the legitimacy of the quantities of the controlled substances 
prescribed, Dr. Brechner, a medical expert in the field of pain 
management and anesthesiology, testified that in 1988, he was consulted 
concerning an aspect of Patient A's treatment, for he had performed a 
facet block procedure to aid in the diagnosis of the source of Patient 
A's back pain. In the course of performing that procedure, he 
administered narcotic analgesics, observing that Patient A had ``an 
extraordinary tolerance to narcotics, even when potentiated with the 
tranquilizers.'' Dr. Brechner also noted that Patient A suffered from 
severe chronic pain and from periods of acute, intractable pain. Dr. 
Brechner concluded that Patient A had received narcotics prescribed in 
amounts that were ``extraordinary compared to the average patient,'' 
because of her extreme tolerance for narcotics, and that she needed the 
narcotics in the amounts prescribed in order to control her pain. He 
testified that prescribing the narcotics in lower doses was not 
effective, and thus, she was not ``over-dosed.'' Also, Dr. Brechner 
testified that alternative means of treatment were tried to control 
Patient A's pain, but that he did not believe such treatment was 
effective alone in treating the pain resulting from her acute pain-
inducing incidents, such as the automobile accident or the fall down 
the stairway. Finally, Dr. Brechner testified that the doctors treating 
Patient A prescribed narcotics for a legitimate medical purpose, to 
treat her pain, and not to maintain her condition as an addict.
    Also, the Respondent testified that he had begun treating Patient A 
at the request of Dr. Roth in 1983. Dr. Skinner testified extensively 
about the acute pain incidents experienced by Patient A through 1988, 
the consulting physicians' diagnoses resulting from these incidents, 
and the various narcotic and non-narcotic treatment regimen implemented 
to control her pain. He also stated that there was no evidence that 
drug intoxication caused any of Patient A's acute events, and that he 
had made an extra effort to insure her lack of toxicity throughout his 
treatment of her. Further, Dr. Skinner testified that all narcotics 
were either administered in the hospital or under the supervision of a 
private duty nurse selected by him from the nursing staff of the 
Chemical Dependency Center at Saint John's Hospital, and that the 
nurses were familiar with Patient A's case, her tolerances, and with 
treating patients who had Patient A's type of problems. As a result of 
his treatment of Patient A, Dr. Skinner concluded that she was not an 
addict: ``She did not demonstrate typical findings of addiction 
behavior * * * never did she evidence toxicity, never did she evidence 
any abstinence withdrawal syndrome, and never did she evidence, while 
under my care at home or in the hospitals, any evidence of street-like 
drug seeking behavior.'' He also stated that, given Patient A's medical 
condition, he did not believe that he over-prescribed controlled 
substances to her. Further, he testified that in prescribing 
medications to Patient A, he would taper her off the medicines to try 
to control her tolerance levels. He strongly denied prescribing 
controlled substances to Patient A to maintain an addiction, stating: 
``if it [is] your contention that I was maintaining an addict, what 
motive would I possibly have for that? It's against all the training 
that I have; it's against everything that I have done in treating 
chemical dependency patients.''
    Also, as to the Respondent's recordkeeping practices, he testified 
that he was aware that tabloid newspapers would pay clerks at the 
hospital to copy celebrity patient records, such as Patient A's, and to 
send the records to the tabloids. Therefore, the Respondent stated he 
was careful in his records to document conditions and prescriptions 

[[Page 62890]]
made to Patient A, while remaining in compliance with federal laws of 
confidentiality.
    As to his future practice, the Respondent stated that if he 
encountered a medically complex patient similar to Patient A, he would 
refer that patient to a chronic pain management specialist. He also 
testified concerning his current practice and the need for his DEA 
Certificate of Registration.
    Pursuant to 21 U.S.C. 824(a)(4) and 823(f), the Deputy 
Administrator may revoke or suspend the Respondent's DEA Certificate of 
Registration and deny any pending application for such registration, if 
he determines that the continued registration would be inconsistent 
with the public interest. Section 823(f) requires that the following 
factors be considered in determining the public interest:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The applicant's conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of controlled 
substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health or 
safety.
    These factors are to be considered in the disjunctive; the Deputy 
Administrator may rely on any one or a combination of factors and may 
give each factor the weight he deems appropriate in determining whether 
a registration should be revoked or an application for registration 
denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-42, 54 FR 16422 
(1989).
    In this case, factors two, four, and five are relevant in 
determining whether the Respondent's continued registration would be 
inconsistent with the public interest. As to factor two, the 
Respondent's ``experience in dispensing * * * controlled substances,'' 
and factor four, the Respondent's compliance with ``Federal, State, or 
local law,'' the Government contends that during March 1986 through 
October 1988, the Respondent prescribed controlled substances in the 
treatment of Patient A not for a legitimate medical purpose and not in 
the usual course of his professional practice, in violation of State 
and Federal law. Specifically, the Government argues that controlled 
substances were prescribed to Patient A during these periods to 
maintain her addiction, and that the amount of narcotics prescribed far 
exceeded what Patient A needed for pain relief.
    An ``addict'' is defined in 21 U.S.C. 802(1) as ``any individual 
who habitually uses any narcotic drug so as to endanger the public 
morals, health, safety, or welfare, or who is so far addicted to the 
use of narcotic drugs as to have lost the power of self-control with 
reference to [one's] addiction.'' There was no dispute that very high 
does of narcotic analgesics were administered to Patient A, but the 
evidence also demonstrated that she had a high tolerance to the 
controlled substances and required this dosage to effectively treat her 
pain. Patient A's medical records and the statements and testimony of 
medical experts established that Patient A had several injuries and was 
plausibly experiencing severe and chronic pain.
    Further, the evidence did not adequately establish that Patient A 
was an ``addict.'' No evidence was presented to show that Patient A had 
acted to ``endanger the public morals, health, safety, or welfare,'' or 
that she had a compulsion to use drugs, had lost control over the 
drugs, or that she continued to use the drugs in spite of adverse 
consequences. Also, medical testimony was presented to establish that, 
although considered, there was no evidence of abstinent syndrome, 
slurred speech, inability to have cognitive speech, nor clinical or 
laboratory evidence of toxicity. However, there was expert testimony to 
establish that use of the controlled substances helped Patient A to 
function and participate in her professional activities in spite of 
chronic pain. Although the Respondent did not deny that Patient A had 
experienced chemical dependency for the control of her pain, he did 
testify that he was not prescribing controlled substances to Patient A 
to maintain an addiction, for she had not presented any addictive 
behavior to him. Therefore, the Deputy Administrator concurs with Judge 
Tenney's finding that the ``preponderance of the evidence demonstrates 
that although Patient A was prescribed a large amount of controlled 
substances, these were prescribed by Dr. Skinner for a legitimate 
medical purpose and in the usual course of his professional practice.''
    The Government also asserted that the Respondent's practices 
violated California Health and Safety Code Sections 11153 and 11154. 
Pursuant to Section 11153(a), a ``prescription for a controlled 
substance shall only be issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of his or her 
professional practice,'' and a prescription issued ``for an addict or 
habitual user of controlled substances, which is issued not in the 
course of professional treatment * * * but for the purpose of providing 
the user with controlled substances, sufficient to keep him or her 
comfortable by maintaining customary use'' would not be a legal 
prescription pursuant to this section. Section 11154 provides in 
relevant part that ``[e]xcept in the regular practice of his or her 
profession, no person shall knowingly prescribe, administer, dispense, 
or furnish a controlled substance to or for any person * * * which is 
not under his or her treatment for a pathology or condition other than 
addiction to a controlled substance * * * .''
    The Respondent asserted that he had prescribed controlled 
substances to Patient A in good faith, and that such prescribing was an 
absolute defense to an allegation of violation of these State law 
provisions. Dr. Ling testified that he accepted that the Respondent 
believed Patient A was in pain, and that he was treating her in good 
faith. Dr. Margoles also testified to the Respondent's good faith 
treatment of Patient A.
    The Deputy Administrator agrees with the conclusion of Judge 
Tenney, that the Respondent did not violate these State code 
provisions. See People v. Lonergan, 219 Cal. App. 3d 82, 90 (1990) 
(acting in ``good faith,'' as defined by California Health and Safety 
Code 11210, exempts a physician from criminal liability under the 
provision of 11153). In response to the Government's exceptions 
relevant to the standard applicable in this administrative proceeding, 
the Deputy Administrator also finds that the preponderance of the 
evidence was against a finding that Patient A was an ``addict'', and 
supports the conclusion that the Respondent had prescribed controlled 
substances to Patient A for a legitimate medical purpose, treating her 
pain, while acting in the usual course of his professional practice. 
Thus, the evidence does not support a finding that the Respondent 
violated the cited State law.
    Next, the Government asserted that from April 1987 through November 
1988, the Respondent performed detoxification or maintenance treatment 
of a narcotic drug-dependent patient without obtaining a registration 
for that purpose, in violation of Federal law. Pursuant to 21 U.S.C. 
802(30), ``detoxification treatment'' is--

the dispensing for a period not in excess of one hundred and eighty 
days of a narcotic drug in decreasing doses to an individual in 
order to alleviate adverse physiological or psychological effects 
incident to withdrawal 

[[Page 62891]]
from the continuous or sustained use of a narcotic drug and as a method 
of bringing the individual to a narcotic drug-free state within such 
period.

Further, the statute defines ``maintenance treatment'' as the 
dispensing, ``for a period in excess of twenty-one days, of a narcotic 
drug in the treatment of an individual for dependence upon heroin or 
other morphine-like drugs.'' 21 U.S.C. 802(29). However, the applicable 
implementing regulation states in pertinent part:

    This section is not intended to impose any limitations on a 
physician * * * to administer or dispense narcotic drugs in a 
hospital to maintain or detoxify a person as an incidental adjunct 
to medical or surgical treatment of conditions other than addiction, 
or * * * to persons with intractable pain in which no relief or cure 
is possible or none has been found after reasonable efforts.

21 CFR 1306.07(c).
    The preponderance of the evidence supports a finding that the 
Respondent was tapering the drugs prescribed to Patient A after acute 
pain resolved. Dr. Ling, as well as others, testified that such 
tapering would be appropriate under such circumstances. Further, the 
record does not establish that Patient A experienced ``adverse 
physiological or psychological effects incident to withdrawal'' nor 
that, in fact, Patient A exhibited behavior consistent with the finding 
that she was an ``addict.'' Therefore, the Deputy Administrator agrees 
with Judge Tenney, that the ``Respondent made a reasonable effort to 
manage the patient's intractable pain and limit the patient's use of 
controlled substances in terms of treatment of [Patient A's] other 
medical conditions, and did not prescribe controlled substances to her 
primarily to wean her from dependence on narcotic analgesics.'' Thus, 
the Respondent was not maintaining Patient A's addiction nor 
detoxifying Patient A without a prior registration.
    Finally, the Government argued that from March 1986 through October 
1988, the Respondent failed to keep adequate medical records of his 
treatment of Patient A, and thus, his prescriptions were not issued for 
a legitimate medical purpose nor in the usual course of professional 
practice in violation of 21 CFR 1306.04, and California Health and 
Safety Code Sections 11168, 11190, and 11191. Yet the Government failed 
to cite to any specific inadequacies of the Respondent's records in 
either their proposed findings of fact or in the exceptions filed to 
the Administrative Law Judge's recommended decision.
    Pursuant to 21 CFR 1304.03(c), a ``registered individual 
practitioner is not required to keep records of controlled substances 
in Schedules II, III, IV, and V which are prescribed in the lawful 
course of professional practice, unless such substances are prescribed 
in the course of maintenance or detoxification treatment of an 
individual.'' Further, a ``registered individual practitioner is not 
required to keep records of controlled substances listed in [Schedules 
II through V] which are administered in the lawful course of 
professional practice unless the practitioner regularly engaged in the 
dispensing or administering of controlled substances and charges 
patients, either separately or together with charges for other 
professional services, for substances so dispensed or administered.'' 
21 CFR 1304.03(d). Here, the Respondent prescribed controlled 
substances to Patient A, but the record does not indicate that he 
``regularly dispensed'' those substances to her nor that he prescribed 
them ``in the course of maintenance or detoxification treatment.'' The 
Deputy Administrator thus agrees with Judge Tenney's conclusion that 
``the Government failed to prove that Respondent kept inadequate 
records. No violation of the Federal statute is found.''
    As for violations of State law, California Health and Safety Code 
Section 11190 provides that a practitioner who issues a prescription of 
a controlled substance classified in Schedule II must make a record for 
each transaction which shows the name and address of the patient, the 
date of the transaction, the ``character, including the name and 
strength, and quantity of controlled substances involved'', and the 
pathology and purpose for which the prescription was issued. The 
Government did not cite to any specific instances where the Respondent 
failed to provide this required information. Thus, after reviewing the 
record, the Deputy Administrator agrees with Judge Tenney's conclusion 
that the ``DEA did not prove that there were recordkeeping violations 
by a preponderance of the evidence.''
    As to factor five, ``such other conduct which may threaten the 
public health and safety,'' the Government argued that the Respondent's 
pattern of prescribing to Patient A caused a threat to the public 
health and safety. As Judge Tenney noted, this is an unusual case for 
it involved the Respondent's prescribing practices for a single 
patient, and no evidence was provided to show a pattern of excessive 
prescribing to any other patients. Further, as to that single patient, 
the Deputy Administrator concurs with Judge Tenney's finding that the 
``overriding purpose of [the] Respondent's prescribing practices was 
the treatment of Patient A's pain,'' a legitimate medical purpose. In 
the balance, the Deputy Administrator finds that it is in the public 
interest for the Respondent to retain his DEA Certificate of 
Registration.
    However, the Deputy Administrator notes with concern the large 
quantities of controlled substances prescribed to Patient A over an 
extended period of time. Yet the conflicting expert opinion evidence 
presented leads to the conclusion that the medical community has not 
reached a consensus as to the appropriate level of prescribing of 
controlled substances in the treatment of chronic pain patients. Given 
this dispute, the Deputy Administrator is reluctant to conclude that 
the Respondent's prescribing of controlled substances to Patient A 
lacked a legitimate medical purpose or was outside the usual course of 
professional practice. It remains the role of the treating physician to 
make medical treatment decisions consistent with a medical standard of 
care and the dictates of the Federal and State law. Here, the 
preponderance of the evidence established that the Respondent so acted.
    Therefore, the Deputy Administrator finds that the public interest 
is best served by taking no action with respect to the continued 
registration of the Respondent. Accordingly, the Deputy Administrator 
of the Drug Enforcement Administration, pursuant to the authority 
vested in him by 21 U.S.C. 823 and 824, and 21 CFR 0.100(b) and 0.104, 
hereby orders DEA Certificate of Registration AS7287534, issued to 
William F. Skinner, M.D., be, and it hereby is, continued, and that any 
pending applications be, and they hereby are, granted. This order is 
effective January 8, 1996.

    Dated: November 30, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-29770 Filed 12-6-95; 8:45 am]
BILLING CODE 4410-09-M